Enforceable Consent Agreement Development for Diethanolamine; Solicitation of Interested Parties and Notice of Public Meeting

ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42203B; FRL-5766-7]

Enforceable Consent Agreement Development for Diethanolamine;

Solicitation of Interested Parties and Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is soliciting interested parties who want to monitor or

participate in negotiations on an enforceable consent agreement (ECA)

concerning the use of pharmacokinetics (PK) studies and mechanistic

data to help meet testing requirements for diethanolamine (CAS No. 111-

42-2) in the proposed hazardous air pollutants (HAPs) test rule. In

addition, EPA invites all interested parties to attend a public meeting

to initiate negotiations on the ECA for diethanolamine.

DATES: EPA must receive written notification requesting designation as

an interested party for diethanolamine on or before February 11, 1998.

Those persons who identify themselves as interested parties for

diethanolamine may submit written comments to EPA on the PK proposal

for this chemical, on EPA's preliminary technical analysis, and on

other materials in the docket for the proposed HAPs test rule, that

relate to the ECA process for this chemical by February 11, 1998.

The public meeting is scheduled from 9:00 a.m. to 5:00 p.m. on

February 24, 1998.

ADDRESSES: Each comment must bear the docket control number OPPTS-

42203B. All comments should be sent in triplicate to: OPPT Document

Control Officer (7407), Office of Pollution Prevention and Toxics,

Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower,

Washington, DC 20460.

EPA will address these comments at the public meeting.

Comments and data may also be submitted electronically to:

[email protected]. following the instructions under Unit VI. of

this document. No Confidential Business Information (CBI) should be

submitted through e-mail.

All comments which contain information claimed as CBI must be

clearly marked as such. Three sanitized copies of any comments

containing information claimed as CBI must also be submitted and will

be placed in the public record for this document. Persons submitting

information on any portion of which they believe is entitled to

treatment as CBI by EPA must assert a business confidentiality claim in

accordance with 40 CFR 2.203(b) for each such portion. This claim must

be made at the time that the information is submitted to EPA. If a

submitter does not assert a confidentiality claim at the time of

submission, EPA will make the information available to the public

without further notice to the submitter.

The public meeting will be held at EPA Headquarters, 401 M St.,

SW., Washington, DC in the EPA Conference Center, North Conference Area

in Room 1.

FOR FURTHER INFORMATION CONTACT: For additional information: Susan B.

Hazen, Director, Environmental Assistance Division (7408), Rm. ET-543B,

Office of Pollution Prevention and Toxics, Environmental Protection

Agency, 401 M St., SW., Washington, DC 20460; telephone: (202) 554-

1404, TDD: (202) 554-0551; e-mail address: TSCA-

H[email protected].

For technical information: Richard W. Leukroth, Jr., Project

Manager, Chemical Control Division (7405), Office of Pollution

Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,

Washington, DC 20460; telephone: (202) 260-0321; fax: (202) 260-8850;

e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Electronic Availability

Internet: Electronic copies of this document and various support

documents are available from the EPA Home Page at the Federal

Register--Environmental Documents entry for this document under ``Laws

and Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/1998/).

II. Background

EPA proposed health effects testing under section 4(a) of the

Toxic Substances Control Act (TSCA) on June 26, 1996, for a number of

HAPs chemicals (61 FR 33178) (FRL-4869-1). As indicated in the proposed

HAPs test rule, EPA would use the data obtained from testing to

implement several provisions of section 112 of the Clean Air Act (CAA),

including the determination of residual risk, the estimation of the

risks associated with accidental releases of chemicals, and

determinations whether substances should be removed from the CAA

section 112(b)(1) list of hazardous air pollutants (delisting). The

data also would be used by other Federal agencies (e.g. Agency for

Toxic Substances and Disease Registry (ATSDR), National

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Institute of Occupational Safety and Health (NIOSH), Occupational

Safety and Health Administration (OSHA), and Consumer Product Safety

Commission (CPSC)) in assessing chemical risks and in taking

appropriate actions within their programs.

In the proposed HAPs test rule, EPA invited the submission of

proposals for pharmacokinetics (PK) studies for the HAPs chemicals,

which could provide the basis for negotiation of ECAs. These PK studies

would be used to inform EPA about the use of route-to-route

extrapolation of toxicity data from routes other than inhalation to

predict the effects of inhalation exposure, as an alternative to

testing proposed under the HAPs test rule. EPA received a PK proposal

for diethanolamine from the Chemical Manufacturers Association,

Alkanolamines Panel (CMA Alkanolamines Panel) on November 25, 1996.

Based on the PK proposal received for diethanolamine, the Agency

developed a preliminary technical analysis. A copy of this preliminary

technical analysis was sent to the CMA Alkanolamines Panel on November

21, 1997. The CMA Alkanolamines Panel reviewed EPA's analysis and

notified EPA on December 31, 1997, that it has a continued interest in

pursuing the ECA process. A copy of the PK proposal, the EPA

preliminary technical analysis and related references, and

correspondence is contained in the public record for this ECA process.

These materials will be used during discussions at the negotiating

meeting. EPA has decided to proceed with the ECA process for

diethanolamine and is providing public notice that the Agency is hereby

initiating the procedures for ECA negotiations for the HAP chemical,

diethanolamine. The procedures for ECA negotiations are described at 40

CFR 790.22(b).

EPA does not intend to publish additional Federal Register

documents to solicit interested parties and announce public meetings to

initiate ECA proceedings for other HAPs chemicals for which PK

proposals were submitted in response to the June 26, 1996 EPA

invitation to submit PK proposals. In a letter dated December 4, 1997,

the Chlorobenzene Producers Association did not express a continued

interest to enter into ECA proceedings for the HAPs chemical 1,2,4-

trichlorobenzene. In the December 24, 1997 amendment to the HAPs

rulemaking (62 FR 67466) (FRL-5742-2), EPA invited the submission of

proposals for ECAs on all the HAPs chemicals for which ECA proposals

have not been received (62 FR 67474). If the Agency receives such

alternative testing proposals and decides to proceed with ECA

proceedings for these proposals, it will publish, as appropriate,

additional Federal Register documents soliciting persons to notify the

Agency in writing of their interest in participating in or monitoring

negotiations for the development of ECAs for the development of

alternative testing to meet HAPs rule testing requirements.

With the publication of this document EPA has published a total of

seven solicitations of interested parties and announcements of public

meetings for ECAs on HAPs chemicals. EPA does not intend to publish

additional Federal Register documents to solicit interested parties and

announce public meetings to initiate ECA proceedings for other HAPs

chemicals for which PK proposals were submitted in response to the EPA

invitation to submit PK proposals that was contained in the original

HAPs proposal, dated June 26, 1996 (61 FR 33178). In a letter to EPA

dated December 4, 1997, the Chlorobenzene Producers Association did not

express a continued interest in entering into ECA proceedings for the

HAPs chemical 1,2,4-trichlorobenzene.

In the December 24, 1997, amendment to the proposed HAPs rule (62

FR 67466), EPA invited the submission of proposals for ECAs on all the

HAPs chemicals for which ECA proposals have not been received. If the

Agency receives such alternative testing proposals and decides to

proceed with ECA proceedings for these proposals, it will publish, as

appropriate, additional Federal Register documents soliciting persons

to notify the Agency in writing of their interest in participating in

or monitoring negotiations for the development of ECAs for alternative

testing to meet HAPs rule testing requirements.

Negotiations on developing an ECA for the HAP chemical,

diethanolamine, will focus on the use of PK studies and mechanistic

data to help meet testing requirements for diethanolamine. In addition,

discussion will include the adequacy of the available data base to be

used for extrapolation to obtain the data needs identified for

diethanolamine in the proposed HAPs test rule, as amended. The

objective of the ECA process is to conclude an ECA that will set in

place an industry-sponsored testing program that will adequately

address EPA's data needs for diethanolamine.

III. Identification of Interested Parties

EPA is soliciting interested parties to monitor or participate in

testing negotiations on an ECA for diethanolamine. The CMA

Alkanolamines Panel, the submitter of the PK proposal for

diethanolamine, and the member companies of the CMA Alkanolamines Panel

are already considered interested parties and do not need to respond to

this document. Additionally, any persons who respond to this document

on or before February 11, 1998 will be given the status of interested

parties. Interested parties must respond in writing to the address

specified in the ``ADDRESSES'' at the beginning of this document. These

interested parties will not incur any obligations by being so

designated. Negotiations will be conducted in one or more meetings open

to the public. The negotiation time schedule for diethanolamine will be

established at the first negotiation meeting and will not exceed a

period of 4 months from the initial meeting. If an ECA is not

established in principle within this timeframe and EPA does not choose

to extend the negotiation time period, negotiations will be terminated

and testing will be required under the final HAPs test rule. If the

testing from the ECA does not meet the Agency's needs, EPA reserves the

right to enter into rulemaking.

IV. Public Participation in Negotiations

Under EPA regulations, the Agency is required to provide the

public with an opportunity to comment on and participate in the

development of ECAs. The procedural rule for ECAs (40 CFR part 790)

contains provisions to ensure that the views of interested parties are

taken into account during the ECA process.

Individuals and groups who respond to this document will have the

status of interested parties. All negotiating meetings for the

development of this ECA for diethanolamine will be open to the public

and minutes of each meeting will be prepared by EPA and placed in the

public docket for this ECA process. The Agency will advise interested

parties of meeting dates and make available meeting minutes, testing

proposals, background documents, and other materials exchanged at or

prepared for negotiating meetings. Where tentative agreement is reached

on an acceptable testing program, a draft ECA will be made available

for comment by interested parties and, if necessary, EPA will hold a

public meeting to discuss any comments that have been received and

determine whether revisions to the ECA are appropriate. EPA will not

reimburse costs incurred by non-EPA participants in this ECA

negotiation process.

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ECAs will only be concluded where an agreement can be obtained

which is satisfactory to the Agency, manufacturers or processors who

are potential test sponsors, and other interested parties, concerning

the need for and scope of testing. In the absence of an ECA, EPA

reserves the right to proceed with rulemaking.

A. The Agency will not enter into an ECA if either:

1. EPA and affected manufacturers or processors cannot reach an

agreement on the provisions of the ECA; or

2. The draft ECA is considered inadequate by other interested

parties who have submitted timely written objections to the draft ECA.

B. EPA may reject these objections if the Agency concludes either

that:

1. They are not made in good faith;

2. They are untimely;

3. They are not related to the adequacy of the proposed testing

program or other features of the agreement that may affect EPA's

ability to fulfill the goals and purposes of TSCA; or

4. They are not accompanied by a specific explanation of the

grounds on which the draft agreement is considered objectionable.

EPA will prepare an explanation of the basis for each ECA. The

explanatory document will summarize the agreement (including the

required testing), explain the objectives of the testing, and outline

the chemical's use and exposure characteristics. The document, which

will also announce the availability of the ECA, will be published in

the Federal Register.

V. Proposal of Export Notification Requirements for Diethanolamine

EPA intends to publish a proposed rule in an upcoming Federal

Register document to require export notification by all persons who

export or intend to export diethanolamine under TSCA section 12(b) upon

the successful conclusion of an ECA for diethanolamine.

VI. Public Record and Electronic Submissions

As described above, diethanolamine is listed as a chemical that

would be subject to testing requirements under the proposed HAPs test

rule, as amended. This ECA negotiation process and the proposed rule,

as amended, are separate and parallel activities. The official record

for this ECA action, including the public version, has been established

under docket control number OPPTS-42203B (including comments and data

submitted electronically as described below). The official record for

this document also includes all material and submissions filed under

docket control number OPPTS-42187A, the record for the proposed HAPs

test rule, as amended, and all materials and submissions filed under

docket control number OPPTS-42187B, the record for the receipt of

alternative testing proposals for developing ECAs for HAPs chemicals.

The official record for this document, including the public

version, which does not include any information claimed as CBI, has

been established for this document under docket control number OPPTS-

42203B. The public version of this record is available for inspection

from 12 noon to 4 p.m., Monday through Friday, excluding legal

holidays. The public record is located in the TSCA Nonconfidential

Information Center, Rm. NE B-607, 401 M St., SW., Washington, DC 20460.

Electronic comments can be sent directly to EPA at:

[email protected].

Electronic comments must be submitted as an ASCII file avoiding

the use of special characters and any form of encryption. Comments and

data will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII

file format. All comments and data in electronic form must be

identified by the docket control number OPPTS-42203B. Electronic

comments on this document may be filed online at many Federal

Depository Libraries.

The record contains the following information:

A. Federal Register notices/EPA documents pertaining to this

notice consisting of:

1. ``Proposed Test Rule for Hazardous Air Pollutants; Proposed

Rule'' (61 FR 33178, June 26, 1996).

2. ``Amended Proposed Test Rule for Hazardous Air Pollutants;

Extension of Comment Period`` (62 FR 67476, December 24, 1997).

B. PK proposal materials consisting of:

1. Chemical Manufacturers Association, Alkanolamine Panel,

`Proposal for Pharmacokinetics Studies of Diethanolamine`` (November

25, 1996).

2. U.S. EPA, ``Preliminary EPA Technical Analysis of Proposed

Industry Pharmacokinetics (PK) Strategy for Diethanolamine`` and cover

letter (November 21, 1997).

List of Subjects

Environmental protection, Chemicals, Hazardous substances,

Reporting and recordkeeping requirements.

Dated: January 13, 1998.

Wardner G. Penberthy,

Acting Director, Chemical Control Division, Office of Pollution

Prevention and Toxics.

[FR Doc. 98-1355 Filed 1-20-98; 8:45 am]

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